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pz98
@pz98
Eminent Member
Joined: Jan 28, 2025
Last seen: Apr 20, 2025
Topics: 0 / Replies: 31
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RE: The scale and process depending on different kinds of changes

One consideration when it comes to the length of times associated with change orders is the regulatory body a project manager is dealing with. The FDA...

2 months ago
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RE: Sustainable Business Models in Project Management

Curing patients could be a sustainable business practice, however it does not seem reasonable. With a business model that prioritizes curing patients,...

2 months ago
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RE: Task scheduling

One important aspect of task scheduling that hasn't been mentioned is the important of incorporating slack when scheduling tasks. Slack is important t...

2 months ago
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RE: Integration of KA in Project Scope Management

Scope management directly influences the cost and time management of a project. As the scope increases, it comes with the expense of a higher cost (us...

2 months ago
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RE: Project Management Knowledge Areas

A project can be well-coordinated while taking account into the 10 knowledge areas is the implementation of a change control process. Managing the 10 ...

2 months ago
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RE: Role of initiation process in medical device project

In regards to the initiation process in medical device projects, one key input is risk management and planning to mitigate risk. This input is often o...

2 months ago
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RE: Should procedures or standards for verification and validation tests be approved by the FDA?

The FDA should have some indirect impact on verification and validation tests. Ideally, these would be guidelines for companies should follow, but sho...

2 months ago
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RE: Enterprise Environmental Factors in Project Management

EEFS should be considered multiple times during the project management lifecycle. As with risk management, holding regular meetings to assess EEFS is ...

2 months ago
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RE: How do you set up a project organization?

One main factor that can contribute to how a project management could set up a project organization can be based off of the overall status of the team...

2 months ago
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RE: Design and Development Plan

Traceability and adaptability requires a systemic change control process in order to maintain efficiency. One example of this would be features embedd...

2 months ago
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RE: Unique Product Lifecycles in Medical Devices

One product that comes to mind when discussing product life cycles is the stethoscope. The acoustic stethoscope has been used since at least the 1850s...

2 months ago
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RE: Regulation Number & Product Code for 510k

Intended use and the technological features of a device is usually the focus when determining which regulations apply to a product. Small distinctions...

2 months ago
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RE: Misclassification of a Device?

Hurdles may not be the right term to use when accidently classifying a device as a Class III instead of a Class II. From a project management prospect...

3 months ago
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RE: Balancing Innovation with Compliance

Regulatory agencies should feel the need to adapt faster to keep up with the innovation happening in the medical device field. As it was mentioned, AI...

3 months ago
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RE: Avoiding Regulatory Pitfalls in Medical Device Project Management

@ms3548 Underestimating regulatory requirements is indeed a common pitfall that does not get enough attention in my view. Implementing steps for early...

3 months ago
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